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NCT03010319 · ClinicalTrials.gov registry record · NA
PriMatrix for the Management of Diabetic Foot Ulcers
A NA study, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- NA
- Development phase
- 226
- Enrollment target
NCT03010319: Completed NA study, sponsored by Integra LifeSciences Corporation.
NCT03010319 is a NA study that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 226 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03010319, a NA study, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 226 participants
- Enrollment target
Study Summary
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.
Primary Outcome
Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.
Interventions
- DEVICE PriMatrix Dermal Repair Scaffold
- DEVICE Secondary Dressings
- DEVICE Offloading device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2017-01 |
| Est. Completion | 2020-08 |
| Phase | NA |
What the finished NCT03010319 record still lists
NCT03010319 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which PriMatrix Dermal Repair Scaffold is the first listed.
NCT03010319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03010319 about?
NCT03010319 is a clinical study titled "PriMatrix for the Management of Diabetic Foot Ulcers". The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.
What is the current status of trial NCT03010319?
This trial is currently completed. It is a NA study. The enrollment target is 226 participants. The study started on 2017-01. Estimated completion is 2020-08.
What interventions are being tested in trial NCT03010319?
The interventions under investigation include: PriMatrix Dermal Repair Scaffold (DEVICE), Secondary Dressings (DEVICE), Offloading device (DEVICE).
Who is sponsoring clinical trial NCT03010319?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03010319's enrollment target sits among peer trials
226 471st of 2000 higher than 1,529 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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